Table 2.
Primary and secondary efficacy endpoints measurements
| Primary endpoint at week 8 (analysis set) | Treatment | Adjusted change from baseline, LSM (SE)† | Difference (Eyluxvi − Eylea) |
||
|---|---|---|---|---|---|
| LSM difference | SE | 95% CI | |||
|
BCVA (letters)* (ITT set) |
Eyluxvi (N = 216) | 5.771 (0.5821) | − 2.092 | 0.6834 | − 3.431 to − 0.753 |
| Eylea (N = 215) | 7.863 (0.5888) | ||||
| Secondary endpoints at week 52 (analysis set) | Treatment | Adjusted change from baseline, LSM (SE)† | Difference (Eyluxvi − Eylea) | ||
|---|---|---|---|---|---|
| LSM difference | SE | 95% CI | |||
|
BCVA (letters)* (ITT set) |
Eyluxvi (N = 216) | 7.315 (0.7871) | − 1.944 | 0.9373 | − 3.781 to − 0.107 |
| Eylea (N = 215) | 9.259 (0.8018) | ||||
|
CST (μm)* (ITT set) |
Eyluxvi (N = 216) | − 116.023 (7.4471) | − 4.742 | 8.808 | − 22.006 to 12.521 |
| Eylea (N = 215) | − 111.281 (7.5733) | ||||
|
Total Size of CNV Area (mm2)* (ITT set) |
Eyluxvi (N = 216) | − 1.890 (0.4174) | 0.233 | 0.4887 | − 0.724 to 1.191 |
| Eylea (N = 215) | − 2.123 (0.4188) | ||||
| Secondary endpoints at week 52 (analysis set) | Treatment | Adjusted proportion (%)§ | Difference (Eyluxvi − Eylea) | ||
|---|---|---|---|---|---|
| Risk difference | SE | 95% CI | |||
|
Participants who lost ≥ 5 letters in BCVA compared with baseline‡ (ITT set) |
Eyluxvi (N = 216) | 10.6 | 6.7 | 2.53 | 1.8–11.7 |
| Eylea (N = 215) | 4.0 | ||||
|
Participants who lost ≥ 10 letters in BCVA compared with baseline‡ (ITT set) |
Eyluxvi (N = 216) | 6.4 | 4.4 | 1.96 | 0.6–8.3 |
| Eylea (N = 215) | 2.0 | ||||
|
Participants who lost ≥ 15 letters in BCVA compared with baseline‡ (ITT set) |
Eyluxvi (N = 216) | 3.4 | 2.5 | 1.43 | − 0.3 to 5.3 |
| Eylea (N = 215) | 1.0 | ||||
|
Participants who gained ≥ 5 letters in BCVA compared with baseline‡ (ITT set) |
Eyluxvi (N = 216) | 68.8 | − 4.2 | 4.52 | − 13.1 to 4.7 |
| Eylea (N = 215) | 72.9 | ||||
|
Participants who gained ≥ 10 letters in BCVA compared with baseline‡ (ITT set) |
Eyluxvi (N = 216) | 41.5 | − 3.3 | 5.05 | − 13.2 to 6.6 |
| Eylea (N = 215) | 44.6 | ||||
|
Participants who gained ≥ 15 letters in BCVA compared with baseline‡ (ITT set) |
Eyluxvi (N = 216) | 19.2 | − 3.0 | 3.93 | − 10.7 to 4.7 |
| Eylea (N = 215) | 21.8 | ||||
|
Participants with intraretinal or subretinal fluid‡ (ITT set) |
Eyluxvi (N = 216) | 39.7 | 0.9 | 4.78 | − 8.5 to 10.2 |
| Eylea (N = 215) | 39.1 | ||||
|
Participants with active CNV leakageঠ(ITT set) |
Eyluxvi (N = 216) | 61.7 | 6.7 | 4.95 | − 3.0 to 16.4 |
| Eylea (N = 215) | 55.1 | ||||
Abbreviations: BCVA best corrected visual acuity, CI confidence interval, CNV choroidal neovascularization, CST central subfield thickness, ITT intention-to-treat, n number of participants with available data at week 52, LSM least squared mean, N number of participants in the ITT set for each treatment group, SE standard error
*Analysis of covariance model was applied with treatment arm (Eyluxvi vs Eylea) and geographic region of enrollment (Europe vs Asia Pacific), baseline BCVA (< 64 letters vs ≥ 64 letters), and screening CST (< 300 μm vs ≥ 300 μm) as fixed factors in the model
†Adjusted change was presented for primary estimand (400 imputations) based on the mean change across all imputations
‡Cochran–Mantel–Haenszel test was applied with treatment arm (Eyluxvi vs Eylea) adjusted for the randomization strata (geographic region at enrollment [Europe vs Asia Pacific], baseline BCVA [< 64 letters vs ≥ 64 letters], and screening CST [< 300 μm vs ≥ 300 μm])
§Adjusted proportion was presented for the primary estimand (400 imputations) based on the proportion across all imputations. Proportion was based on imputed data
¶The result > 0 (mm2) was counted as active CNV leakage